Menstruation DisturbancesNCT05928650
Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-Athletic Females
An observational study of Menstruation Disturbances, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level. Read more about this study
- Who is it for?
- Ages 16 to 19 years, women only
- Conditions the study is for
- Menstruation Disturbances
- What is being tested?
- Evaluation of menstrual function
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- Women only
- Child, Adult
Study population: Egyptian sprinters, long marathon runners, and non-athletic females
Who may be able to join
- Virginal females.
- Their age ranged from 16 to 19years.
- All females had the same socio-economic status.
- For athletic groups only:
- They have been starting the practice of sport at least one year before the onset of menarche.
Who cannot join
- Females who had been used oral contraceptives or any hormonal treatment in the previous six months.
- Smoking.
- History of chronic disease.
- Having any psychiatric problems.
- For athletic groups only:
- injured females who were absent from training for at least three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-athletic Females: An Observational Study
The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.
Read the detailed description
Menstrual function and dysfunction conversations have long been stigmatized both in the general population and in sport settings (O'Flynn, 2006). However, Discussions of menstruation in the sport context often focuses on the impact of physical menstrual symptoms and dysfunction on activities such as training and sport performance (Bruinvels et al., 2016; Knowles et al., 2019). In addition, no study had been compare between sprinters and long-marathon runners in menstrual characteristics and estradiol level. Therefore, the purpose of this study to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.
- Conditions
- Menstruation Disturbances
- Being tested
- Evaluation of menstrual function
- Keywords
- Menstrual function, Serum estradiol levels, Sprinters, Long Marathon Runners, Non-Athletic Females
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of menstrual functionOther
Evaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes.
| Study group | Role | What they receive |
|---|---|---|
| Sprinters | Sprinters Receives: Other: Evaluation of menstrual function | |
| Long marathon runners | Long marathon runners Receives: Other: Evaluation of menstrual function | |
| Non-athletic Females | Non-athletic Females Receives: Other: Evaluation of menstrual function |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum estradiol level
Blood samples were obtained on the 2nd day of the menstrual cycle at 10.00 a.m. following overnight fasting and rest. The athletic females were instructed to refrain from performing strenuous exercise on the day of sampling. Blood samples were separated and stored at -80°C till analysis of serum estradiol levels. Serum estradiol levels were measured to evaluate the menstrual function. The manufacturer indicated the following reference intervals for healthy females: Estradiol 40-350 pg/ml.
Measured: 3 months
Menstrual history characteristics
The age at menarche (in years), the number of menstrual cycles in the past year, and the length of menstrual cycles (in days) were collected through a self-administered questionnaire to evaluate the menstrual status of each female participant.
Measured: 3 months
Age of participation to sport
It was taken in years from each female athlete through a self-administered questionnaire.
Measured: 3 months
Weekly training workload
It was taken in hours per week from each female athlete through a self-administered questionnaire.
Measured: 3 months
Training experience
The training experience of the athlete was then calculated by subtracting her age of participation in sport from her chronological age.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 May 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation DisturbancesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Doaa Osman, Principal investigator, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928650
- Sponsor's protocol ID
- P.T.REC/012/004550
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Menstrual Function Among Sprinters, Long Marathon Runners, and Non-athletic Females: An Observational Study
- ClinicalTrials.gov ID
- NCT05928650
- Acronym / sponsor ID
- P.T.REC/012/004550
- Conditions
- Menstruation Disturbances
- Keywords
- Menstrual function, Serum estradiol levels, Sprinters, Long Marathon Runners, Non-Athletic Females
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.
Detailed description
Menstrual function and dysfunction conversations have long been stigmatized both in the general population and in sport settings (O'Flynn, 2006). However, Discussions of menstruation in the sport context often focuses on the impact of physical menstrual symptoms and dysfunction on activities such as training and sport performance (Bruinvels et al., 2016; Knowles et al., 2019). In addition, no study had been compare between sprinters and long-marathon runners in menstrual characteristics and estradiol level. Therefore, the purpose of this study to compare between sprinters and long marathon in menstrual characteristics and serum estradiol level.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sprinters | – | Other: Evaluation of menstrual functionSprinters |
| Long marathon runners | – | Other: Evaluation of menstrual functionLong marathon runners |
| Non-athletic Females | – | Other: Evaluation of menstrual functionNon-athletic Females |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Egyptian sprinters, long marathon runners, and non-athletic females
Key inclusion criteria (5 listed)
- Virginal females.
- Their age ranged from 16 to 19years.
- All females had the same socio-economic status.
- They have been starting the practice of sport at least one year before the onset of menarche.
Key exclusion criteria (6 listed)
- Females who had been used oral contraceptives or any hormonal treatment in the previous six months.
- Smoking.
- History of chronic disease.
- Having any psychiatric problems.
- injured females who were absent from training for at least three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of menstrual functionEvaluation of serum estradiol levels and menstrual history characteristics between sprinters, long marathon runners and non-athletes. | Other | Long marathon runners, Non-athletic Females, Sprinters |
Primary outcome
serum estradiol level
Time frame: 3 months
Blood samples were obtained on the 2nd day of the menstrual cycle at 10.00 a.m. following overnight fasting and rest. The athletic females were instructed to refrain from performing strenuous exercise on the day of sampling. Blood samples were separated and stored at -80°C till analysis of serum estradiol levels. Serum estradiol levels were measured to evaluate the menstrual function. The manufacturer indicated the following reference intervals for healthy females: Estradiol 40-350 pg/ml.
Menstrual history characteristics
Time frame: 3 months
The age at menarche (in years), the number of menstrual cycles in the past year, and the length of menstrual cycles (in days) were collected through a self-administered questionnaire to evaluate the menstrual status of each female participant.
Age of participation to sport
Time frame: 3 months
It was taken in years from each female athlete through a self-administered questionnaire.
Weekly training workload
Time frame: 3 months
It was taken in hours per week from each female athlete through a self-administered questionnaire.
Training experience
Time frame: 3 months
The training experience of the athlete was then calculated by subtracting her age of participation in sport from her chronological age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa Osman principal investigator
Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstruation Disturbances, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum estradiol level (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.